Adherence Toolkit for Managing Nonadherence to HIV Medications in Indonesia

University of Groningen

Status: Not yet enrolling

Conditions: Adult; HIV Infections

Treatments: Behavioral: Adherence toolkit

Study type: Interventional

Funder types: Other

Identifiers

NCT05996081

V1-072023

Details and patient eligibility

About

The goal of this usability study and a cluster randomised controlled trial is to investigate the effectiveness of an adherence toolkit as a decision support tool to improve adherence to antiretroviral therapy. The main questions it aims to answer are: 1) is the adherence toolkit useable and acceptable among HIV care providers in Indonesian clinical practice? and 2) is the adherence toolkit superior than the usual care in improving adherence to antiretroviral therapy among people living with HIV in Indonesia? HIV clinics in Surabaya, Indonesia, will be recruited to participate in the study. HIV care providers will be included in the usability study, whereas people living with HIV will be enrolled in the cluster randomised controlled trial. People living with HIV will be randomly assigned in a 1:1 ratio to the control group receiving usual HIV care and the intervention group receiving an intervention using the adherence toolkit in addition to usual HIV care.

Full description

Consistent adherence to antiretroviral therapy (ART) is important to maintain viral suppression and good quality of life among people living with HIV. However, maintaining a high level of ART adherence is challenging because adherence is a complex behaviour and many factors contribute to nonadherence. Therefore, a decision support tool is proposed to help HIV care providers in addressing the barriers and providing the adherence-promoting interventions tailored to the individual needs. The present study comprises a usability assessment followed by a cluster randomised controlled trial to investigate the effectiveness of the adherence toolkit as a decision support tool on improving adherence to ART. Twelve HIV clinics in Surabaya, Indonesia, will be randomised 1:1 to the control (usual care) and intervention (adherence toolkit and usual care) group. The intervention period will last for 12 months, with outcome measures will be collected at initiation, 3-, 6-, and 12-month post-initiation. The primary outcome is adherence to ART measured using a self-reported adherence questionnaire and pharmacy refill records. The secondary outcomes include clinical outcomes (viral load, CD4), HIV treatment knowledge, medication beliefs, and health-related quality of life. The findings will enable HIV care providers, people living with HIV, and policy makers to make informed decision about the value of the adherence toolkit for being used in daily clinical practice.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Doctors, nurses, and pharmacists who have been trained to provide HIV care and treatment by the Indonesian Ministry of Health
• People living with HIV who have been receiving any ART regimens for at least six months, aged 18 years and older, with any coinfection or comorbidity, suspected to be nonadherent to HIV medications (e.g., having sustained treatment interruptions, inconsistent prescription refill, increased viral load >1,000 copies/ml, decreased CD4 count <200 cells/mm3, or developed opportunistic infections), and provided informed consent

Exclusion criteria

• People who have severe mental or physical constraints, drop-out or withdraw after the commencement of the trial

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Control

No Intervention group

Description:

Individuals in the HIV clinics randomised to the control or intervention group will attend a consultation session as a usual HIV care based on the Indonesian guideline for HIV care and treatment (Ministry of Health Regulation No. 23/2022). Although it may slightly vary by clinic, for every visit they will collect their medications and receive general information from the HIV care provider on the prescribed ART regimens, including the dose, time of administration, potential side effects and how to deal with them, and the importance of adherence. They will be followed-up at the same time points as those in the intervention group.

Intervention

Experimental group

Description:

Individuals attending the HIV clinics that are randomised to the intervention group will receive an intervention over 12 months in addition to usual care. The intervention using an adherence toolkit will be delivered during regular clinic visits when they collect their medications.

Treatment:

Behavioral: Adherence toolkit